Auditory Functions in Patients With Multiple Sclerosis

May 11, 2026 updated by: Arianna Di Stadio, University of Catania

Electrophysiological Studies of Auditory Functions and CSF Analyses in Patients With Multiple Sclerosis

The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). CSF will be collected by lumbar puncture and analyzed looking for inflammatory markers.

The results of DPOAE and CSF will be correlated to identify statistically significant correlation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Case-Control study

Tools for patients' selection and inclusion in the study

STEP one

  • Full medical records detailed for neurological diseases
  • Brain and spinal cord MRI performed 12 months (n1) before and most recent one (n2)
  • Lumbar puncture
  • Blood test
  • Questionnaire for screening hearing disorders
  • App for screening hearing loss

STEP two

  • Pure Tone Auditory test + Tympanometry and Stapedial Reflex
  • Speech Perception test
  • In case of tinnitus: tinnitus questionnaire and acuphenometry
  • DPOAEs
  • ABR

STEP three in case of Hearing impairment

- MRI Tractography

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Sicily
      • Catania, Sicily, Italy, 95121
        • Recruiting
        • Arianna Di Stadio
        • Contact:
        • Sub-Investigator:
          • Athanasia Warnecke, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy patients and patients with RRMS

Description

Inclusion Criteria

  • age >18 and <50,
  • no history of hearing loss,
  • no psychiatric condition
  • no familial history of otosclerosis/deafness/genetic hearing loss
  • patients with PD and/or MS.

Exclusion Criteria

  • Conductive hearing loss
  • stroke < 2 years
  • cardiovascular disease non under control
  • diabetes
  • hypotensive disorders
  • alcohol abuse
  • recreational drug consumption
  • epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Healthy patients between 20 and 40 years
Diagnostic test: Auditory test

The patients will perform:

Pure Tone Auditory test + Tympanometry and Stapedial Reflex

  • Speech Perception test
  • In case of tinnitus: tinnitus questionnaire and acuphenometry
  • DPOAEs
  • ABR
Other: CSF sampling
Cerebrospinal Fluid will be collected by lumbar puncture and analyzed
MS group
Patient with Relapsing Remitting MS age between 20 and 40 years
Diagnostic test: Auditory test

The patients will perform:

Pure Tone Auditory test + Tympanometry and Stapedial Reflex

  • Speech Perception test
  • In case of tinnitus: tinnitus questionnaire and acuphenometry
  • DPOAEs
  • ABR
Other: CSF sampling
Cerebrospinal Fluid will be collected by lumbar puncture and analyzed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory functions and correlation with CSF findings
Time Frame: 12 months
The worsening of the hearing thresholds and DPOAE results will be correlated with the presence of inflammatory elements in the CSF
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Collaborators

Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSSNHL2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

24 months for 12 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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